DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions and Claim Status
Applicant’s arguments and amendments filed 12/14/25 are acknowledged. Any objection or rejection from the 7/16/25 office action that is not addressed below is withdrawn based on the amendments.
Previously, the species of sodium bicarbonate was elected.
The elected species was found in the prior art and claims to the elected species are rejected as set forth below.
Claims 2-4 and 17 have been canceled.
Claims 1, 5-16 and 18-21 are being examined.
Priority
A priority section appeared in the previous office action. Since the claims have been amended, this section is updated to correspond to the instant claims.
This application is a CIP of 15/150,094 05/09/2016 ABN.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 15/150,094, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
In the instant case, claims 1, 11 and 19 refer to ‘foaming’.
Claim 1 and dependents refer to ‘foams in a wound only upon contact with water in blood’.
Claim 11 and dependents refer to ‘foam when it contacts water in blood’.
Claim 19 and dependents refer to ‘foaming upon contact with water present in blood’.
As discussed below the claims are unclear and contain new matter.
As recited in claims 1, 11 and 19 the claims appear to require a sheet or mixture that contains at least anhydrous sodium bicarbonate which is contacted with water.
Essential learning products entry (retrieved from https://www.essentiallearningproducts.com/fizz-or-not-fizz-john-cowens on 9/7/17, 2 pages; previously cited) teach that nothing happens when sodium bicarbonate is added to water (page 1 section 1). As such, an additional ingredient is required for the foaming action. The only anhydrous component listed is sodium bicarbonate.
Claims 1, 11 and 19, although unclear, appear to suggest that tranexemic can be used with sodium bicarbonate for the foaming action.
However, applicants own claim 5 recognizes that the tranexemic acid is a pharmaceutical.
Although the specification uses the phrase “tranexemic acid” there is no basis in the specification that “tranexemic acid” can be used as a foaming agent. Claims 1, 11 and 19 have specifically removed the phrase ‘anhydrous acetic acid’ so the foaming action, which is a required feature, has to come from somewhere.
Application 15/150,094 does not support the use of “tranexemic acid” as a foaming agent. There is no basis for this in the specification nor is there any basis that tranexemic acid actually reacts with sodium bicarbonate. Instant claims 11 and 19 recite “tranexemic acid and/or alginic acid and a pharmaceutical clotting agent” and then recites “wherein the pharmaceutical clotting agent is formed of 0.2% to 14.5% tranexemic acid with 0.3% to 5% chitosan in a base of 5% to 45% alginic acid”. Thus, the claims appear to give the tranexemic acid multiple functions, specifically a foaming agent and pharmaceutical. However, there is no basis in the specification to use tranexemic acid as a foaming agent. One cannot pick and choose disparate parts of the specification and later paste them together and call it the invention. The courts have previously stated (In re Ruschig, 379 F.2d 990, 154 USPQ 118 (CCPA 1967)): one cannot disclose a forest in the original application, and then later pick a tree out of the forest and say "here is my invention."
As set forth in MPEP 716.02 VI D ‘If the application is a continuation-in-part of an earlier U.S. application or international application, any claims in the new application not supported by the specification and claims of the parent application have an effective filing date equal to the filing date of the new application.’. For at least the reasons above, the effective filing date of instant claims 1, 5-16 and 18-21 is at best 6/2/19.
Response to Arguments - Priority
Applicant's arguments filed 12/14/25 have been fully considered but they are not persuasive.
Although applicants argue that the claims have been amended, the amended claims are addressed above.
Although applicants argue that the office action refers to tranexemic acid and/or alginic acid, the mere mention of terms does not mean that there is support for them in a particular context for a particular function. Instant claims 11 and 19 recite “tranexemic acid and/or alginic acid and a pharmaceutical clotting agent” and then recites “wherein the pharmaceutical clotting agent is formed of 0.2% to 14.5% tranexemic acid with 0.3% to 5% chitosan in a base of 5% to 45% alginic acid”. Thus, the claims appear to give the tranexemic acid multiple functions, specifically a foaming agent and pharmaceutical. However, there is no basis in the specification to use tranexemic acid as a foaming agent. One cannot pick and choose disparate parts of the specification and later paste them together and call it the invention. The courts have previously stated (In re Ruschig, 379 F.2d 990, 154 USPQ 118 (CCPA 1967)): one cannot disclose a forest in the original application, and then later pick a tree out of the forest and say "here is my invention."
Claim Rejections - 35 USC § 112
Claims were previously rejected under 112. Since the claims have been amended, the rejection is updated to correspond to the instant claims.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 5-16 and 18-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
In the instant case, claims 1, 11 and 19 refer to ‘foaming’.
Claim 1 and dependents refer to ‘foams in a wound only upon contact with water in blood’.
Claim 11 and dependents refer to ‘foam when it contacts water in blood’.
Claim 19 and dependents refer to ‘foaming upon contact with water present in blood’.
As recited in claims 1, 11 and 19 the claims appear to require a sheet or mixture that contains at least anhydrous sodium bicarbonate which is contacted with water.
Essential learning products entry (retrieved from https://www.essentiallearningproducts.com/fizz-or-not-fizz-john-cowens on 9/7/17, 2 pages; previously cited) teach that nothing happens when sodium bicarbonate is added to water (page 1 section 1) and that sodium bicarbonate (i.e. baking soda) reacts under acidic conditions to release carbon dioxide (page 1 section 1). As such, an additional ingredient is required for the foaming action. The only anhydrous component listed is sodium bicarbonate.
Better bones entry (retrieved from https://www.betterbones.com/alkaline-balance/why-an-alkaline-diet-makes-sense/ on 9/7/17, 18 pages; previously cited) teach that blood pH is tightly regulated between 7.35 and 7.45 (page 3 5th bullet point) and thus is basic. Since the reference above teach that sodium bicarbonate releases CO2 under acidic conditions and that water in blood is basic the mechanism of action is unclear.
Claims 1, 11 and 19 appear to suggest that tranexemic can be used with sodium bicarbonate for the foaming action. However, applicants own claim 5 recognizes that the tranexemic acid is a pharmaceutical.
Although the specification uses the phrase “tranexemic acid” there is no basis in the specification that “tranexemic acid” can be used as a foaming agent. Claims 1, 11 and 19 have specifically removed the phrase ‘anhydrous acetic acid’ so the foaming action, which is a required feature, has to come from somewhere.
Stated another way, although the claims requiring a ‘foaming’ functionality the specific reaction that is to occur is unclear (this issue was also raised in the parent application, a copy of the board decision was provided on 5/1/20). The claims appear to be lacking a critical feature (see MPEP 2172.01).
Further, the language used causes confusion as to what limitations (if any) that references related to ‘only upon contact with water in blood’ imply. It is unclear if the claim language relates to the solubility of certain components or to some other feature.
Claim 11 recites ‘medical grade’. Tapecon medical grade entry (retrieved from https://www.tapecon.com/blog/what-does-it-mean-for-materials-to-be-medical-grade on 7/7/25, 7 pages; previously cited) states that medical grade can have different interpretations (page 2 2nd paragraph) and teach that there is not a simple, hard and fast definition of medical grade for materials (page 2 3rd paragraph). The term “medical grade” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, the determination of what falls within the scope of the claim appears to be subjective. Although unclear, claim 11 has been interpreted as including no new matter.
Claim 19 recites ‘disperses’. Claim 11 recites ‘taking a form of sheets’. MPEP 2113 recognizes that claims can recite processing steps. However, in the instant case, it is unclear if phrases such as ‘disperse’ imply a method step or if it is describing a functional property or an intended use. Stated another way, it is unclear if the compositions are the products after the processing steps or if they merely need to be capable of undergoing such steps. It appears that the claims refer to different compositions at different points in time making it unclear what composition is required. A sheet that is rolled up (as recited in claim 11) is quite different from a sheet that is ‘dispersed’ (as recited in claim 19 for example). Further, a composition that has been contacted water is quite different from an anhydrous composition (as recited in claim 1 for example). A gel is not necessarily the same as a powder which is not necessarily the same as a liquid (as recited in claim 11). It is unclear how a composition can be both anhydrous yet be formed by contacting water. The dependent claims do not clarify the claim scope.
The last 2 lines of claim 21 recites ‘the foaming gel’. There is insufficient antecedent basis for this limitation in the claim. The word ‘foaming’ in claim 11 line 2 has been deleted.
The last 2 lines of claim 6 recites ‘the insertion mechanism inserted into or onto the wound’. There is insufficient antecedent basis for this limitation in the claim. The phrase ‘arranged in a wound’ in claim 1 line 5 has been deleted.
Instant claims 11 and 19 recite “tranexemic acid and/or alginic acid and a pharmaceutical clotting agent” and then recites “wherein the pharmaceutical clotting agent is formed of 0.2% to 14.5% tranexemic acid with 0.3% to 5% chitosan in a base of 5% to 45% alginic acid”. In similar fashion claim 5 refers to pharmaceuticals. Thus, the claims appear to recite tranexemic acid twice - as a sheet component (presumably asserted to be a foaming agent) and as a pharmaceutical. When it is recited twice, it is unclear what the concentration is in relation to - the total or one of the individual components. The same arguments apply to the use of alginic acid.
Although unclear, the claims are interpreted as being enabled. Although the claims do not recite acetic acid, the claims use the open ended comprising language which allows for the inclusion of acetic acid.
The rejection set forth below is a new rejection necessitated by amendment.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5-16 and 18-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP 2163 recites: New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement.
In the instant case, claims 1, 11 and 19 refer to ‘foaming’.
Claim 1 and dependents refer to ‘foams in a wound only upon contact with water in blood’.
Claim 11 and dependents refer to ‘foam when it contacts water in blood’.
Claim 19 and dependents refer to ‘foaming upon contact with water present in blood’.
Claims 1, 11 and 19 have specifically removed the phrase ‘anhydrous acetic acid’ so the foaming action, which is a required feature, has to come from somewhere.
As recited in claims 1, 11 and 19 the claims appear to require a sheet or mixture that contains at least anhydrous sodium bicarbonate which is contacted with water.
Essential learning products entry (retrieved from https://www.essentiallearningproducts.com/fizz-or-not-fizz-john-cowens on 9/7/17, 2 pages; previously cited) teach that nothing happens when sodium bicarbonate is added to water (page 1 section 1). As such, an additional ingredient is required for the foaming action. The only anhydrous component listed is sodium bicarbonate.
Claims 1, 11 and 19, although unclear, appear to suggest that tranexemic can be used with sodium bicarbonate for the foaming action.
However, applicants own claim 5 recognizes that the tranexemic acid is a pharmaceutical.
Although the specification uses the phrase “tranexemic acid” there is no basis in the specification that “tranexemic acid” can be used as a foaming agent. Claims 1, 11 and 19 have specifically removed the phrase ‘anhydrous acetic acid’ so the foaming action, which is a required feature, has to come from somewhere. The courts have previously stated (In re Ruschig, 379 F.2d 990, 154 USPQ 118 (CCPA 1967)): one cannot disclose a forest in the original application, and then later pick a tree out of the forest and say "here is my invention." Thus, there is no adequate support for the current claims.
Response to Arguments - 112
Applicant's arguments filed 12/14/25 have been fully considered but they are not persuasive with respect to the rejections set forth above.
Although applicants argue that the claims have been amended, the amended claims are addressed above.
Although applicants argue that claim 11 was previously interpreted as including no new matter, a 112(a)/1st rejection is separate and distinct from a 112(b)/2nd rejection. Further, the amended claims raise new issues as discussed above.
Although applicants argue that the word disperse has been deleted, claim 19 line 4 recites ‘disperses’.
Claim Rejections - 35 USC § 103
Claims were previously rejected based on the references cited below. Since the claims have been amended the rejections are updated.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 5-16 and 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pickett (US 2017/0319739; ‘Pickett’; previously cited) in view of Falus G. (US 2010/0256671; ‘Falus’ as cited with IDS 6/3/19).
Pickett teach a foaming composition where the composition is rolled into sheets that are affixed to an insertion mechanism and teach the composition as anhydrous (claims 1 and 4). Pickett teach sodium bicarbonate as a foaming agent (section 0016) and teach that the composition is water or blood activated (section 0008). Pickett teach in the form of a field dressing (sections 0004 and 0029). Pickett teach that the hemostat can introduce pharmaceuticals (abstract). Pickett teach the inclusion of a clotting agent that is 0.2% to 14.5% tranexemic acid with 0.3% to 5% chitosan in a base of 5% to 45% alginic acid calcium salt (section 0019). Pickett teach the form of a gel where the gel is formed from prescription-grade collagen powder with anhydrous ethyl alcohol (section 0016). Pickett teach that the stick holds the hemostat in the wound (section 0024). Pickett teach pressure with applying a wound dressing and foam pressure within the wound (section 0012). Pickett teach a foaming hemostat comprising a first mixture formed from mixing a gelling agent and a sterile anhydrous liquid and a foaming agent and a clotting agent where the foam pressure presses the gel into damaged areas (claim 11). Pickett teach foaming hemostats (abstract) including with a field dressing (section 0029), with an insertion mechanism that is a sterile stick or wire (section 0006), with a cover shield (section 0006), with an x-ray or radiation marker (section 0006), with detectors (section 0006), with a tube (section 0006) and a clotting agent (section 0006). Pickett teach sheets (section 0006). Pickett teach a foaming agent, clotting agent, gelling agent and liquid (section 0006). Pickett teach the inclusion of additional agents including shock mitigation agents (section 0006). Pickett teach that no foreign matter is introduced (abstract). Pickett teach that there is no need to remove matter at a later time (abstract). Pickett teach the inclusion of dyes (section 0006).
Pickett does not recite anhydrous acetic acid (which although not currently recited in the claims is known to allow for the claimed functionality as discussed below).
Falus teach hemostatic foams (abstract). Falus teach that sodium bicarbonate (NaHCO3) reacts with acetic acid which can be used to induce a foam to release carbon dioxide (sections 0028 and 0131 and claim 25). Falus teach a foaming reaction between bicarbonate and acetic acid (section 0131 and figure 2). Falus teach the compositions as biodegradable and nontoxic (section 0030). Falus teach the parts as being solubilized in a medium (section 0068). Falus teach that the formulations comprise sodium bicarbonate and thrombin (section 0071) and teach the agents in sterilized form (sections 0047 and 0190-0194). Falus teach the formulation as a gel (sections 0008, 0010, 0015, 0069 and 0105). Falus teach that the components are able to stop bleeding (section 0017). Falus teach that the foam is distributed throughout the site (section 0028).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Pickett because Pickett teach sodium bicarbonate as a foaming agent (section 0016) and teach that the composition is water or blood activated (section 0008) and anhydrous (claim 1). Thus one would have been motivated to use the known components taught by Falus that allow for foaming. Falus teach that sodium bicarbonate (NaHCO3) reacts with acetic acid which can be used to induce a foam to release carbon dioxide (sections 0028 and 0131 and claim 25). Since Pickett teach hemostats with specific components and functions one would have been motivated to make such hemostats. Falus teach the compositions as biodegradable and nontoxic (section 0030). Pickett teach the inclusion of a clotting agent that is 0.2% to 14.5% tranexemic acid with 0.3% to 5% chitosan in a base of 5% to 45% alginic acid calcium salt (section 0019). Pickett teach the form of a gel where the gel is formed from prescription-grade collagen powder with anhydrous ethyl alcohol (section 0016). Pickett teach foaming hemostats (abstract) including as a field dressing (section 0029), with an insertion mechanism that is a sterile stick or wire (section 0006), with a cover shield (section 0006), with an x-ray marker (section 0006), with detectors (section 0006), with a tube (section 0006) and a clotting agent (section 0006). Pickett teach sheets (section 0006). Pickett teach a foaming agent, clotting agent, gelling agent and liquid (section 0006). Pickett teach the inclusion of additional agents including shock mitigation agents (section 0006) and dyes (section 0006). Pickett teach that no foreign matter is introduced (abstract). Pickett teach that there is no need to remove matter at a later time (abstract). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Pickett based on the specific suggestions of Pickett and the nature of the problem to be solved (see also MPEP 2143 IA). One would have had a reasonable expectation of success because the references recognize the compositions as hemostatic.
In relation to claim 1, Pickett teach a foaming composition where the composition is rolled into sheets that are affixed to an insertion mechanism and teach the composition as anhydrous (claims 1 and 4). Pickett teach sodium bicarbonate as a foaming agent (section 0016) and teach that the composition is water or blood activated (section 0008). Falus teach a foaming reaction between bicarbonate and acetic acid (section 0131 and figure 2). Claim 1 uses the open ended comprising language allowing for the presence of acetic acid. Since Pickett teach the hemostat is anhydrous (claim 1), one would have included the acetic acid in such form. Pickett teach that no foreign matter is introduced (abstract). Pickett teach that there is no need to remove matter at a later time (abstract). Falus teach the compositions as biodegradable and nontoxic (section 0030). Pickett teach pressure with applying a wound dressing and foam pressure within the wound (section 0012). Pickett teach spreading of the foam throughout the wound (section 0016). Further, Pickett teach that the hemostat can introduce pharmaceuticals (abstract). Falus teach that the foam is distributed throughout the site (section 0028). Pickett teach the inclusion of a clotting agent that is 0.2% to 14.5% tranexemic acid with 0.3% to 5% chitosan in a base of 5% to 45% alginic acid calcium salt (section 0019).
In relation to claim 5, Pickett teach that the hemostat can introduce pharmaceuticals (abstract). Falus teach that the foam is distributed throughout the site (section 0028). Pickett teach the inclusion of a clotting agent that is 0.2% to 14.5% tranexemic acid with 0.3% to 5% chitosan in a base of 5% to 45% alginic acid calcium salt (section 0019).
In relation to claim 6, Pickett teach foaming hemostats (abstract) with an insertion mechanism that is a sterile stick or wire into the wound (section 0006).
In relation to claims 7 and 10, Pickett teach foaming hemostats (abstract) with a cover shield and tube (section 0006).
In relation to claims 8-9, Pickett teach foaming hemostats (abstract) with an x-ray marker (section 0006) and with detectors (section 0006).
In relation to claim 11, Pickett teach a foaming hemostat comprising a first mixture formed from mixing a gelling agent and a sterile anhydrous liquid and a foaming agent and a clotting agent where the foam pressure presses the gel into damaged areas (claim 11). Pickett teach the form of a gel where the gel is formed from prescription-grade collagen powder with anhydrous ethyl alcohol (section 0016). Pickett teach sodium bicarbonate as a foaming agent (section 0016) and teach that the composition is water or blood activated (section 0008). Pickett teach a clotting agent (section 0006). Pickett teach the inclusion of a clotting agent that is 0.2% to 14.5% tranexemic acid with 0.3% to 5% chitosan in a base of 5% to 45% alginic acid calcium salt (section 0019). Falus teach a foaming reaction between bicarbonate and acetic acid (section 0131 and figure 2). Claim 11 uses the open ended comprising language which allows for the inclusion of acetic acid. Since Pickett teach the hemostat is anhydrous (claim 1), one would have included the acetic acid in such form. Pickett teach that no foreign matter is introduced (abstract). Pickett teach that there is no need to remove matter at a later time (abstract). Falus teach the compositions as biodegradable and nontoxic (section 0030). Pickett teach spreading of the foam throughout the wound (section 0016).
In relation to claim 12, Pickett teach the inclusion of additional agents including shock mitigation agents (section 0006).
In relation to claim 13, Pickett teach foaming hemostats (abstract) with an insertion mechanism that is a sterile stick or wire (section 0006).
In relation to claims 14-15, Pickett teach pressure from the foaming agent (section 0007) and water activation (section 0016). Pickett teach that no foreign matter is introduced (abstract). Pickett teach that there is no need to remove matter at a later time (abstract). Falus teach the compositions as biodegradable and nontoxic (section 0030).
In relation to claim 16, Pickett teach sodium bicarbonate as a foaming agent (section 0016) and teach that the composition is water or blood activated (section 0008). Falus teach a foaming reaction between bicarbonate and acetic acid (section 0131 and figure 2). Since Pickett teach the hemostat is anhydrous (claim 1), one would have included the acetic acid in such form. Falus teach that the formulations comprise sodium bicarbonate (section 0071 and claim 25) which is applicants elected species and has been interpreted as meeting the claim limitation.
In relation to claim 18, Pickett teach that the hemostat can introduce pharmaceuticals (abstract). Falus teach that the foam is distributed throughout the site (section 0028).
In relation to claim 19, Pickett teach a foaming composition where the composition is rolled into sheets that are affixed to an insertion mechanism and teach the composition as anhydrous (claims 1 and 4). Pickett teach sodium bicarbonate as a foaming agent (section 0016) and teach that the composition is water or blood activated (section 0008) and teach a clotting agent (section 0006). Pickett teach foaming hemostats (abstract) including with an insertion mechanism that is a sterile stick or wire (section 0006), with a cover shield (section 0006) with a tube (section 0006). Falus teach that the formulation is delivered via an applicator through a needle (sections 0033, 0112 and figure 4) and teach the agents in sterilized form (sections 0047 and 0190-0194). Falus teach a foaming reaction between bicarbonate and acetic acid (section 0131 and figure 2). Claim 19 uses the open ended comprising language which allows for the presence of acetic acid. Since Pickett teach the hemostat is anhydrous (claim 1), one would have included the acetic acid in such form. Falus teach the compositions as biodegradable and nontoxic (section 0030). Pickett teach spreading of the foam throughout the wound (section 0016). Pickett teach the inclusion of a clotting agent that is 0.2% to 14.5% tranexemic acid with 0.3% to 5% chitosan in a base of 5% to 45% alginic acid calcium salt (section 0019).
In relation to claim 20, Pickett teach the inclusion of additional agents including shock mitigation agents (section 0006).
In relation to claim 21, Pickett teach the inclusion of anhydrous components specifically dyes (section 0006).
Although unclear, the prior art has been interpreted as suggesting the claimed limitations.
Claims 1, 5-16 and 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pickett (US 2017/0319739; ‘Pickett’; previously cited) in view of Scherr GH (US 2007/0237811; ‘Scherr’; previously cited).
Pickett teach a foaming composition where the composition is rolled into sheets that are affixed to an insertion mechanism and teach the composition as anhydrous (claims 1 and 4). Pickett teach sodium bicarbonate as a foaming agent (section 0016) and teach that the composition is water or blood activated (section 0008). Pickett teach in the form of a field dressing (sections 0004 and 0029). Pickett teach that the hemostat can introduce pharmaceuticals (abstract). Pickett teach the inclusion of a clotting agent that is 0.2% to 14.5% tranexemic acid with 0.3% to 5% chitosan in a base of 5% to 45% alginic acid calcium salt (section 0019). Pickett teach the form of a gel where the gel is formed from prescription-grade collagen powder with anhydrous ethyl alcohol (section 0016). Pickett teach that the stick holds the hemostat in the wound (section 0024). Pickett teach pressure with applying a wound dressing and foam pressure within the wound (section 0012). Pickett teach a foaming hemostat comprising a first mixture formed from mixing a gelling agent and a sterile anhydrous liquid and a foaming agent and a clotting agent where the foam pressure presses the gel into damaged areas (claim 11). Pickett teach foaming hemostats (abstract) including with a field dressing (section 0029), with an insertion mechanism that is a sterile stick or wire (section 0006), with a cover shield (section 0006), with an x-ray or radiation marker (section 0006), with detectors (section 0006), with a tube (section 0006) and a clotting agent (section 0006). Pickett teach sheets (section 0006). Pickett teach a foaming agent, clotting agent, gelling agent and liquid (section 0006). Pickett teach the inclusion of additional agents including shock mitigation agents (section 0006). Pickett teach that no foreign matter is introduced (abstract). Pickett teach that there is no need to remove matter at a later time (abstract). Pickett teach the inclusion of dyes (section 0006).
Pickett does not recite anhydrous acetic acid (which although not currently recited in the claims is known to allow for the claimed functionality as discussed below).
Scherr teach wound dressings (abstract). Scherr teach that acetic acid and sodium bicarbonate react to produce a foam (section 0021) which results in an enhanced surface area to enhance the absorption of blood (section 0046). Scherr teach for a more immediate hemostasis (section 0020). Scherr recognizes that the chitosan is degraded in situ (section 0008) and also recognize the dissolving of the chitosan (section 0021).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Pickett because Pickett teach sodium bicarbonate as a foaming agent (section 0016) and teach that the composition is water or blood activated (section 0008) and in anhydrous form (claim 1). Thus one would have been motivated to use the known components taught by Scherr that allow for foaming. Scherr teach that acetic acid and sodium bicarbonate react to produce a foam (section 0021) which results in an enhanced surface area to enhance the absorption of blood (section 0046). Since Pickett teach the hemostat is anhydrous (claim 1), one would have included the acetic acid in such form. Since Pickett teach hemostats with specific components and functions one would have been motivated to make such hemostats. Pickett teach that the hemostat can introduce pharmaceuticals (abstract). Pickett teach the inclusion of a clotting agent that is 0.2% to 14.5% tranexemic acid with 0.3% to 5% chitosan in a base of 5% to 45% alginic acid calcium salt (section 0019). Pickett teach the form of a gel where the gel is formed from prescription-grade collagen powder with anhydrous ethyl alcohol (section 0016). Pickett teach foaming hemostats (abstract) including as a field dressing (section 0029), with an insertion mechanism that is a sterile stick or wire (section 0006), with a cover shield (section 0006), with an x-ray marker (section 0006), with detectors (section 0006), with a tube (section 0006) and clotting agent (section 0006). Pickett teach sheets (section 0006). Pickett teach a foaming agent, clotting agent, gelling agent and liquid (section 0006). Pickett teach the inclusion of additional agents including shock mitigation agents (section 0006). Pickett teach that no foreign matter is introduced (abstract). Pickett teach that there is no need to remove matter at a later time (abstract). Scherr teach for a more immediate hemostasis (section 0020). Scherr recognizes that the chitosan is degraded in situ (section 0008) and also recognize the dissolving of the chitosan (section 0021). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Pickett based on the specific suggestions of Pickett and the nature of the problem to be solved (see also MPEP 2143 IA). One would have had a reasonable expectation of success because the references recognize the compositions as hemostatic. Further, Scherr teach that acetic acid and sodium bicarbonate react to produce a foam (section 0021) which results in an enhanced surface area to enhance the absorption of blood (section 0046).
In relation to claim 1, Pickett teach a foaming composition where the composition is rolled into sheets that are affixed to an insertion mechanism and teach the composition as anhydrous (claims 1 and 4). Pickett teach sodium bicarbonate as a foaming agent (section 0016) and teach that the composition is water or blood activated (section 0008). Scherr teach that acetic acid and sodium bicarbonate react to produce a foam (section 0021) which results in an enhanced surface area to enhance the absorption of blood (section 0046). Since Pickett teach the hemostat is anhydrous (claim 1), one would have included the acetic acid in such form. Instant claim 1 uses open ended comprising language which allows for the presence of acetic acid. Pickett teach that no foreign matter is introduced (abstract). Pickett teach that there is no need to remove matter at a later time (abstract). Scherr teach for a more immediate hemostasis (section 0020). Scherr recognizes that the chitosan is degraded in situ (section 0008) and also recognize the dissolving of the chitosan (section 0021). Pickett teach pressure with applying a wound dressing and foam pressure within the wound (section 0012). Pickett teach spreading of the foam throughout the wound (section 0016). Further, Pickett teach that the hemostat can introduce pharmaceuticals (abstract). Pickett teach the inclusion of a clotting agent that is 0.2% to 14.5% tranexemic acid with 0.3% to 5% chitosan in a base of 5% to 45% alginic acid calcium salt (section 0019).
In relation to claim 5, Pickett teach that the hemostat can introduce pharmaceuticals (abstract). Pickett teach the inclusion of a clotting agent that is 0.2% to 14.5% tranexemic acid with 0.3% to 5% chitosan in a base of 5% to 45% alginic acid calcium salt (section 0019).
In relation to claim 6, Pickett teach foaming hemostats (abstract) with an insertion mechanism that is a sterile stick or wire into the wound (section 0006).
In relation to claims 7 and 10, Pickett teach foaming hemostats (abstract) with a cover shield and tube (section 0006).
In relation to claims 8-9, Pickett teach foaming hemostats (abstract) with an x-ray marker (section 0006) and with detectors (section 0006).
In relation to claim 11, Pickett teach a foaming hemostat comprising a first mixture formed from mixing a gelling agent and a sterile anhydrous liquid and a foaming agent and a clotting agent where the foam pressure presses the gel into damaged areas (claim 11). Pickett teach sodium bicarbonate as a foaming agent (section 0016) and teach that the composition is water or blood activated (section 0008). Scherr teach that acetic acid and sodium bicarbonate react to produce a foam (section 0021) which results in an enhanced surface area to enhance the absorption of blood (section 0046). Since Pickett teach the hemostat is anhydrous (claim 1), one would have included the acetic acid in such form. Instant claim 11 uses open ended comprising language which allows for the presence of acetic acid. Pickett teach a clotting agent (section 0006). Pickett teach the inclusion of a clotting agent that is 0.2% to 14.5% tranexemic acid with 0.3% to 5% chitosan in a base of 5% to 45% alginic acid calcium salt (section 0019). Pickett teach the form of a gel where the gel is formed from prescription-grade collagen powder with anhydrous ethyl alcohol (section 0016). Scherr teach that acetic acid and sodium bicarbonate react to produce a foam (section 0021) which results in an enhanced surface area to enhance the absorption of blood (section 0046). Pickett teach that no foreign matter is introduced (abstract). Scherr recognizes that the chitosan is degraded in situ (section 0008) and also recognize the dissolving of the chitosan (section 0021). Pickett teach that there is no need to remove matter at a later time (abstract). Pickett teach spreading of the foam throughout the wound (section 0016).
In relation to claim 12, Pickett teach the inclusion of additional agents including shock mitigation agents (section 0006).
In relation to claim 13, Pickett teach foaming hemostats (abstract) with an insertion mechanism that is a sterile stick or wire (section 0006).
In relation to claims 14-15, Pickett teach pressure from the foaming agent (section 0007) and water activation (section 0016). Pickett teach that no foreign matter is introduced (abstract). Pickett teach that there is no need to remove matter at a later time (abstract). Scherr teach dissolving of materials (section 0021).
In relation to claim 16, Pickett teach sodium bicarbonate as a foaming agent (section 0016) and teach that the composition is water or blood activated (section 0008). Scherr teach that acetic acid and sodium bicarbonate react to produce a foam (section 0021) which results in an enhanced surface area to enhance the absorption of blood (section 0046).
In relation to claim 18, Pickett teach that the hemostat can introduce pharmaceuticals (abstract).
In relation to claim 19, Pickett teach a foaming composition where the composition is rolled into sheets that are affixed to an insertion mechanism and teach the composition as anhydrous (claims 1 and 4). Pickett teach sodium bicarbonate as a foaming agent (section 0016) and teach that the composition is water or blood activated (section 0008) and teach a clotting agent (section 0006). Pickett teach the inclusion of a clotting agent that is 0.2% to 14.5% tranexemic acid with 0.3% to 5% chitosan in a base of 5% to 45% alginic acid calcium salt (section 0019). Pickett teach the form of a gel where the gel is formed from prescription-grade collagen powder with anhydrous ethyl alcohol (section 0016). Pickett teach foaming hemostats (abstract) including with an insertion mechanism that is a sterile stick or wire (section 0006), with a cover shield (section 0006) with a tube (section 0006). Pickett teach spreading of the foam throughout the wound (section 0016). Scherr recognizes that the chitosan is degraded in situ (section 0008) and also recognize the dissolving of the chitosan (section 0021). Since Pickett teach the hemostat is anhydrous (claim 1), one would have included the acetic acid in such form. Instant claim 19 uses open ended comprising language which allows for the presence of acetic acid.
In relation to claim 20, Pickett teach the inclusion of additional agents including shock mitigation agents (section 0006).
In relation to claim 21, Pickett teach the inclusion of anhydrous components specifically dyes (section 0006).
Although unclear, the prior art has been interpreted as suggesting the claimed limitations.
Response to Arguments - 103
Applicant's arguments filed 12/14/25 have been fully considered but they are not persuasive with respect to the rejections set forth above.
Although applicants argue about priority, the instant claim priority is addressed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658